Inspections, Compliance, Enforcement, and Criminal Investigations
Xoran Technologies Inc 25-Mar-08
Department of Health and Human Services
Public Health Service
March 25, 2008
RETURN RECEIPT REQUESTED
President, Chief Executive Officer
Xoran Technologies, Inc.
309 N. First Street
Ann Arbor, MI 48103
Dear Mr. Sukovic:
During an inspection of your firm located in Ann Arbor, Michigan on August 30, 2007 through October 26, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the MiniCAT CT System. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C, § 321(h), this product is considered a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease or are intended to affect the structure or function of the body.
This inspection revealed that this device is adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation found at Title 21, Code of Federal Regulations(CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to document in the Design History Files (DHF) the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, as required by 21 CFR § 820.30(g). For example, the MiniCAT CT System DHF did not contain test methods, equipment specifications to support equivalency, and supporting test data such as supporting image scans.
2. Failure to maintain a complete Device Master Record (DMR) that includes all the elements required by 21 CFR § 820.181. For example, the DMR does not include or refer to the location of all device and software specifications, all production and process specifications, or all installation, maintenance, and servicing procedures and methods.
3. Failure to ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer's instructions and procedures and that the inspection and any test results are documented to demonstrate proper installation, as required by 21 CFR § 820.170(b). For example, your firm failed to perform and document the Orbital Calibration test during onsite installation of the MiniCAT CT System.
4. Failure to maintain a Device History Record (DHR) that includes, or refers to the location of, the primary identification label and labeling-used for each production unit, as required by 21 CFR § 820.184(e). For example, your firm did not retain identification labels for the MiniCAT CT System in the DHR.
5. Failure to maintain procedures to control document approval and distribution, as required by 21 CFR § 820.40(a). For example, documents, such as testing and installation instructions, that were not approved were observed at a location where they were being used.
6. Failure to validate and document the validation of computer software used as part of production or the quality system, as required by 21 CFR § 820.70(i). For example, the firm failed to validate and document the validation of computer software used to calculate the Geometric Calibration test and the Resolution Phantom test used as part of finished product testing for the MiniCAT System.
7. Failure to conduct quality audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR § 820.22. For example, assembly and installation instructions are not controlled documents and they have not been audited.
8. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR § 820.50(a). For example, your firm failed to provide documentation demonstrating that certain component suppliers were evaluated and that their products were approved for use in the assembly and installation of the MiniCAT CT System.
9. Failure to document that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR § 820.25(b). For example, CGMP and Quality System regulation training were not documented for employees having direct responsibility in manufacturing, testing, and installation of the MiniCAT CT system.
10. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system, as defined by 21 CFR § 820.3(v), to ensure that the quality system satisfies the requirements of 21 CFR § 820.20, as is evident by the observations listed above.
We acknowledge the December 13, 2007 letter, signed by Dr. Amy Kim, Manager of Regulatory Affairs, responding to the Inspectional Observations, Form FDA 483 (FDA 483) which was issued at the closeout of the inspection. The response letter describes commitments toward corrective action and implementing procedures, policies, and documentation system to improve the effectiveness of the quality. However, we have concluded that the response is inadequate because there are no specific steps outlined to correct the violations and prevent their recurrence. We believe that you need to fully evaluate your record keeping system to ensure that additional deviations will not occur, specifically your Design History Files, Device Master Records, Device History Records, and Production Monitoring. Please submit copies of any revised procedures pertaining to the observations listed above. We request that you highlight the changes you make to identify the revised text. these procedures so that FDA can readily. Additionally, your response indicates a Quality System regulation consultant has been obtained. We encourage you to ensure consultants and your component suppliers are fully evaluated per 21 CFR § 820.50.
You should take prompt action to correct the violations addressed in this letter: Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts. Additionally, no premarket submission to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter as to the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again of the corrective action you have taken. Include documentation. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, please state the reason for the delay and the time within which the corrections will be completed.
Your written response should be sent to Paige E. Wilson, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan, 48207. If you have any questions about the content of this letter please contact Paige E. Wilson at (313) 393-8100.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483, issued at the closeout of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the cause of the violations, and take prompt actions to correct the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Joann M. Givens
Detroit District Office